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Completed

NCT Number: NCT05768724

Two Different Dietary Interventions for Girls With Polycystic Ovary Syndrome

This study was conducted to evaluate the efficacy of the MEtabolic Syndrome REduction in NAvarra (RESMENA) diet versus a control diet based on American Heart Association (AHA) recommendations for the treatment of PCOS in adolescents with obesity and PCOS. A total of 40 adolescents diagnosed with PCOS between the ages of 13-18 years were randomized to either a Resmena or control diet for 6 months. Dietary status, anthropometry, body composition, biochemical parameters, and reproductive endocrine hormones were compared between the 2 groups before and after the intervention.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Androgen; Hypersecretion Body Weight Cysts Diet, Healthy Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Obesity Ovarian Cysts Ovarian Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases

Age range

13 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Esra Döğer

Ankara, 06500, Turkey (Türkiye)

About this study

The purpose of this study was to investigate the effect of a high meal frequency, low carbohydrate, high protein, high n-3 PUFA, healthy fatty acid and antioxidant content, low glycemic load Resmena diet or a control diet based on AHA recommendations on anthropometric measurements, body composition, insulin resistance, lipid metabolism levels, inflammatory markers and reproductive endocrine levels in adolescents with obesity and PCOS..Randomized controlled study design was used in the study. Patients in the study were allocated to the control and study intervention groups. Participants were invited to face-to-face interviews at the beginning of the study and monthly for 6 months.

Anthropometric measurements, body composition analysis, and a physical activity questionnaire were performed at the beginning and end of the study, and three-day food consumption records and blood samples for the measurement of biochemical parameters were collected. In addition, the physical activity and food consumption records of the participants were repeated in monthly controls and their anthropometric measurements and body composition were analyzed and compared.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of PCOS in adolescent girls according to the Rotterdam criteria
  • Age 13-18 years,
  • Body mass index (BMI) ≥ 95th percentile

Exclusion criteria

  • Other endocrine etiological disorders (Cushing's syndrome, congenital adrenal hyperplasia, McCune Albright syndrome, mutations in the glucocorticoid receptor gene, ovarian and adrenal androgen-secreting tumors, hyperprolactinemia, diabetes mellitus, thyroid dysfunction, adrenal, and other endocrine disorders),
  • Cardiovascular and cerebrovascular diseases,
  • Hematologic disorders
  • Liver and kidney failure
  • Mental disorders
  • Eating disorders
  • Contraceptive use in the last 3 months
  • Use of insulin-sensitizing agents
  • Use of drugs affecting lipid metabolism (such as fish oil)
  • Smoking.

Treatment and study plan

intervention diet

Behavioral

The Resmena diet: It was characterized by a higher meal frequency, consisting of seven meals/d (including breakfast, lunch, dinner, and two snacks in the morning and two snacks in the afternoon), and by a different macronutrient distribution; 40% total energy value from CHO, 30% from proteins and 30% from lipids. This pattern tried to reinforce high n-3 polyunsaturated FA (n-3 PUFA) and high natural antioxidant food consumption and promoted low GL CHO intake as well as a high adherence to the Mediterranean diet. It also maintained a healthy FA profile and a cholesterol content of less than 300 mg/day.

  • Daily meal plans were created according to the energy intake of the participants and sent to the participants via social media every week. Participants were asked to keep 3-day diet records to evaluate their compliance with the diet and were invited to the research center once a month to be checked.

Control diet

Behavioral

Control diet: It was based on the American Heart Association (AHA) guidelines, including 3-5 meals per day, a macronutrient distribution of 55% total energy value from carbohydrates, 15% proteins, and 30% lipids, a healthy fatty acids (FA) profile and a cholesterol consumption lower than 300 mg/day.

  • Daily meal plans were created according to the energy intake of the participants and sent to the participants via social media every week. Participants were asked to keep 3-day diet records to evaluate their compliance with the diet and were invited to the research center once a month to be checked

Primary outcomes

  1. Luteinizing hormone (LH) (IU/L)

    Time frame: change between the first day and the sixth month of the study

    Participants' serum LH levels was determined.

  2. Follicle-stimulating hormone (FSH) (IU/L)

    Time frame: change between the first day and the sixth month of the study

    Participants' serum FSH levels was determined.

  3. Total and free (ng/mL)

    Time frame: change between the first day and the sixth month of the study

    Participants' serum FSH levels was determined.

  4. Prolactin (ng/mL)

    Time frame: change between the first day and the sixth month of the study

    Participants' serum prolactin levels was determined.

  5. Dehydroepiandrosterone sulfate (DHEA-S) (µg/dL)

    Time frame: change between the first day and the sixth month of the study

    Participants' serum DHEA-S levels was determined.

  6. Androstenedione (ng/mL)

    Time frame: change between the first day and the sixth month of the study

    Participants' serum androstenedione was determined.

  7. 17-hydroxyprogesterone (17-OH progesterone) (ng/mL)

    Time frame: change between the first day and the sixth month of the study

    Participants' serum 17-OH progesterone was determined.

  8. Sex hormone binding globulin (SHGB) (nmol/L)

    Time frame: change between the first day and the sixth month of the study

    Participants' serum SHGB was determined.

  9. Free Androgen Index (FAI)

    Time frame: change between the first day and the sixth month of the study

    Free Androgen Index (FAI) was calculated according to the equation FAI = [(Total testosterone/ SHBG) × 100]

  10. The Ferriman-Gallwey score (FGS)

    Time frame: change between the first day and the sixth month of the study

    The Ferriman-Gallwey score (FGS) was used to evaluate hirsutism.

  11. fasting blood glucose (mg/dl)

    Time frame: change between the first day and the sixth month of the study

    Participants' fasting blood gucose was calculated.

  12. fasting insulin (IU/ml)

    Time frame: change between the first day and the sixth month of the study

    Participants' fasting insulin was calculated.

  13. HOMA-IR index

    Time frame: change between the first day and the sixth month of the study

    Participants' HOMA-IR index value was calculated using the "fasting blood glucose (mmol/L) x fasting insulin (μU/mL)/22.5" formula

  14. QUICKI index

    Time frame: change between the first day and the sixth month of the study

    Participants' QUICKI index was calculated using the 1/[log(fasting insulin in μU/ml)+log(fasting glucose in mg/dl)].

Secondary outcomes

  1. Total cholesterol (mg/dl) composition

    Time frame: change between the first day and the sixth month of the study

    Participants' serum total cholesterol was determined.

  2. high-density lipoprotein (HDL-C) (mg/dl)

    Time frame: change between the first day and the sixth month of the study

    Participants' serum HDL-C was determined.

  3. low-density lipoprotein (LDL) (mg/dl)

    Time frame: change between the first day and the sixth month of the study

    Participants' serum LDL-C was determined.

  4. triglyceride (mg/dl)

    Time frame: change between the first day and the sixth month of the study

    Participants' serum triglyceride was determined.

  5. high-sensitivity CRP (HsCRP)(mg/l)

    Time frame: change between the first day and the sixth month of the study

    Participants' serum HsCRP was determined.

  6. tumor necrosis factor-alpha (TNF-α) (pg/ml)

    Time frame: change between the first day and the sixth month of the study

    Participants' serum TNF-α determined.

  7. interleukin-6 (IL-6) (pg/ml)

    Time frame: change between the first day and the sixth month of the study

    Participants' serum IL-6 determined.

  8. Weight in kilograms

    Time frame: change between the first day and the sixth month of the study

    Body weight measurement was made.

  9. Height in meters

    Time frame: change between the first day and the sixth month of the study

    Height was measured

  10. BMI = body mass index (kg/m2)

    Time frame: change between the first day and the sixth month of the study

    BMI = [body weight (kg)/(height [m])2]' was calculated

  11. Neck circumference in cm

    Time frame: change between the first day and the sixth month of the study

    Neck circumference was measured

  12. . Waist circumference in cm

    Time frame: change between the first day and the sixth month of the study

    waist circumference was measured

  13. body composition analysis

    Time frame: change between the first day and the sixth month of the study

    body composition analysis (fat mass /kg), fat percentage (%), fat-free mass (kg)) were made by using the InBody 720 (1-1000 kHz; InBody Co., Ltd. Korea)

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Beneficial Effects of Resemena Diet on Anthropometric, Metabolic and Reproductive Profile in Adolescents With Obesity and Polycystic Ovary Syndrome: a Randomized Controlled Intervention Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 14, 2023
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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